DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES

K103321 · Dana Products, Inc. · FRC · Feb 16, 2011 · General Hospital

Device Facts

• Record ID: K103321
• Device Name: DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
• Applicant: Dana Products, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Feb 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The disposable polypropylene sleeve assembly with 3M's 1292 Bl used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.

Device Story

Device is a disposable polypropylene sleeve assembly used in conjunction with the Dana Reusable Test Pack (K092944) and 3M 1292 Biological Indicator. System functions as a challenge pack for monitoring pre-vacuum steam sterilization cycles (10 minutes at 270°F). Used by sterile processing personnel in clinical environments to verify sterilization efficacy. Output is a biological indicator result indicating whether sterilization parameters were met. Benefits include standardized challenge to sterilization process, ensuring instrument sterility and patient safety.

Clinical Evidence

Bench testing only.

Technological Characteristics

Polypropylene sleeve assembly; designed for use with 3M 1292 Biological Indicator and Dana Reusable Test Pack. No electronic components, software, or energy sources.

Indications for Use

Indicated for routine monitoring of 10-minute 270°F pre-vacuum steam sterilization cycles in healthcare settings using the Dana Reusable Test Pack.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

• Dana Reusable Test Pack (K092944)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Mr. Harry Bala President Dana Products. Incorporated 7 Corey Drive South Barrington, Illinois 60010

FEB 16 251

Re: K103321

Trade/Device Name: Reusable Biological Test Pack for Steam Sterilization Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: January 20, 2011 Received: January 28, 2011

Dear Mr. Bala:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Bala

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony V. Water

Anthony D. Watson, M.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K103321

Device Name: Reusable Biological Indicator Test Pack for Steam Sterilization.

Indications For Use:

The disposable polypropylene sleeve assembly with 3M's 1292 Bl used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(División Sign-Off) Page 1 of 1
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K103321